Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Cataract Clinical Trial

Official title:

Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653520
• Other study ID #: ANES001
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: November 4, 2017

Study information

• Verified date: August 2018
• Source: Avanti Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.

Description:

The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: November 4, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center

Exclusion Criteria:

• Age <18 years

• Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness

• Allergy to a medication in protocol

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Diazepam
5 or 10mg
• Tramadol
50mg or 100mg
• Ondansetron
1 or two tabs
• MKO melt
1 or 2 MKO melts

Locations

Country	Name	City	State
United States	Memorial Hermann Kirby Glen Surgery Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Avanti Anesthesia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient who needed additional IV medication for cataract surgery	Patients who require IV medications for self-reported pain or anxiety during surgery.	1 day